Exel

Associate Clinical Data Management Director

Alameda, CA · Director

Sponsorship not specified$163k-$231kDetected 31 days ago

GCPProject ManagementProcess ImprovementClinical TrialsFDA RegulatoryLeadershipCommunicationCollaborationPublic Speaking

About the role

SUMMARY/JOB PURPOSE: Provide oversight for the execution of oncology data management activities at the program level (for an indication or for multiple studies within an indication) from study start up through to regulatory submission.
Participate in staff recruitment, onboarding, training, and mentoring. *** This position is located at Exelixis beautiful headquarters overlooking the bay in Alameda, CA.
The base pay range for this position is $163,000 - $231,000 annually.

Lead the planning and execution of data management activities on assigned studies
Ensure all Data Management study documents are developed and archived
Establish and lead the Data Working Group (DWG) for assigned study
Develop and maintain Data Management timelines
Track and manage progress towards data deliverables through effective metrics tracking, analysis, and reporting
Provide a high level of expertise in data management to support clinical studies.
Provide clear verbal or written information and hands-on support to project team members and to CROs related to eCRF and database design, data quality, and reporting of database / data quality status.
Develop and execute procedures for data quality review and data acceptance prior to data analyses and/or database lock.
Manage data transfers with CROs and third-party data sources, SAE/AE reconciliation and MedDRA /WHO-DD coding.
Support the transfer, locking, and archiving of study databases. Manage scheduling and time constraints across multiple projects.

BS/BA degree in related discipline and a minimum of 11 years of related experience
MS/MA degree in related discipline and a minimum of 9 years of related experience
PhD in related discipline and a minimum of 5 years of related experience
It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

A minimum of 7 years of clinical data management experience is also required in the pharmaceutical industry or clinical trials.
A minimum of 4 years in a project leadership role
Experience with Electronic Data Capture (EDC) is required and experience with Interactive Voice or Web Response Systems (IVRS/IWRS) is preferred.
Demonstrated experience leading data management teams is preferred

The ability to problem solve and have people/project leadership skills.
Knowledge of GCP is essential.
General knowledge of FDA regulations that govern the execution of clinical trials and Electronic Data Capture (EDc) systems required
Expertise in CDASH/CDISC standards preferred.
Has extensive experience in relevant industry/profession and area of specialization.
Uses professional concepts and company objectives to resolve complex issues in creative and effective ways.
Has complete understanding and wide application of technical principles, theories, concepts, and techniques.
Has good general knowledge of other related disciplines.
Applies strong analytical and business communication skills.
Demonstrated Data Management Project Management skills
Excellent verbal and written communication skills and interpersonal skills are required.
Education/Experience:

The base pay range for this position is $163,000 - $231,000 annually.
The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location.

The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors.
Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan.

This listing is sourced directly from Exel's careers page and normalized into a canonical job model.